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The Food and Drug Administration (FDA) recently rejected applications from both Charlotte’s Web and Irwin Naturals to use a hemp extract as a dietary supplement. In both cases, much of the reasoning behind the FDA decision involved a lot of ground previously covered – such as the use of CBD in Epidiolex, a pharmaceutical drug already approved for use by the FDA excluding it from being the active ingredient in a dietary supplement.
The Charlotte’s Web letter did include some further intriguing information. In it, the FDA noted that: “In addition, none of the clinical and pre-clinical studies that you provided adequately address certain reported toxicity endpoints of CBD such as hepatotoxicity and reproductive toxicity.” Charlotte’s Web roundly rejected this assertion in a response to the FDA in which it clearly expressed frustration with the entirety of the process of engaging with the FDA over its application.
The FDA’s rejection of the data does present a number of questions. Presumably Charlotte’s Web included data from the ValidCare industry study on liver toxicity that it took a large role in getting underway. Where then does that leave the study and its data in terms of FDA acceptance? ValidCare had said it was establishing communications with the FDA to discuss the results, which had found no evidence of liver toxicity and that it would provide a pathway for the FDA to access the raw, blinded, aggregate data for its analysis.
Similarly, the FDA presumably saw safety data for Epidiolex with CBD at a higher dosage, which it approved as safe for use in a pharmaceutical. Why then would the safety of a lower dose still be questioned? Does it mean the FDA is going to be very strict over safety data matching the exact blend of cannabinoids in the product? And will it require each individual company to show safety rather than determine the overall safety of cannabinoids as a general group? Both applications were for full-spectrum extracts whereas the Epidiolex data – which is likely protected by commercial confidentiality anyway – was for CBD in isolate.
No matter the answers to the individual questions, the overall cautious approach the FDA took to the applications was not surprising. That then begs the question why the companies bothered to go through the extra effort and expense of engaging with the FDA on these issues – particularly given the presumption that the US Congress will eventually approve a pathway to market for CBD and spectrum products – initially assumed to be as dietary supplements.
Perhaps the companies were unsure whether this would go ahead in a timely manner. Perhaps they were unsure whether any such pathway would include dietary supplements as an allowable use. It could also be that simply because the US Congress creates a pathway, it does not mean the FDA will not require further steps to gain market approval – such as ensuring the safety of the product like what would be required under the dietary supplement applications.
But as a back-up plan to Congressional approval, applying for dietary supplement usage had significant drawbacks. It had to be assumed, given the FDA reluctance in the area, to be a bit of a long-shot – not ideal for your back-up plan. Perhaps then the companies were simply trying to suss out the system ahead of any approval just to see how interacting with the FDA in a more official application capacity would work. But this was surely a costly and time-consuming way to do that.
There is also potential speculation that the companies were assembling evidence of intransigence on behalf of the FDA if the agency continued to push back against market approval of products in a post legal-pathway-to-market world. Such evidence could be useful ammunition in a potential lawsuit to try and force action through the courts if it came to that.
All in all, the actions do throw up more questions than answers – despite much of the results being unsurprising. CBD-Intel will continue to work on providing answers to the various questions that have arisen.
*Under CBD-Intel’s editorial discretion
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